Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: MEDTRONIC SYNERGYST II MODEL 7070 PULSE GENERATOR
• Classification Name: implantable pacemaker pulse-generator
• Generic Name: pulse generator
• Regulation Number: 870.3610
• Applicant: MEDTRONIC VASCULAR
• PMA Number: P890003
• Supplement Number: S005
• Date Received: 10/30/1990
• Decision Date: 12/27/1990
• Product Code: DXY [ Registered Establishments with DXY ]
• Advisory Committee: Cardiovascular
• Supplement Type: normal 180 day track
• Supplement Reason: location change - other
• Expedited Review Granted?: No
• Combination Product: No